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Quality Assurance Sr. Executive
2 weeks ago
Jamjoom Pharma has in a very short span of time emerged, as one of the leading pharmaceutical companies in the Afrasia region. The geographical focus of the company is on countries in the Middle East, Africa, and CIS regions. Strategic focus on selected therapeutic categories has contributed to the rapid growth, market acceptance, and overall success of the company.
**Role Summary**:
Quality Assurance person is responsible for providing evidence that all information necessary to determine that the product fit for the intended use is gathered evaluated and approved. To involve, coordinate and control the activity that fulfill the quality requirements.
**Responsibilities**:
- Batch records documents receiving, auditing and corrections.
- Review the batch record and identify any incomplete data and calculations, ensure that its content is completed and all process complies with the approved procedures.
- Check that any OOS, NCMR / Deviation, Change request related to the batch are recorded, investigated and disposed properly.
- Check for the batch yield & accountability.
- Write all comments and findings on the audit form and attached on the batch record for correction.
- Communicate to the different concern departments any findings observed during batch record audit.
- Report for any deviation observed during batch record audit.
- Ensure compliance of related SOP’s and keep updated.
- Managing all activities related to controlled drugs as per SFDA guidelines including new manufacturing requests, new transfer requests and destruction requests.
- Follow the safety and hygiene system as per the company’s policy.
- To follow Quality Policy and maintain GMP.
- Registration of released finished goods batches in the IBRCS (Importing, Batch Release and Clearance System) as per Saudi Food and Drug requirements.
- Registration of released finished goods batches in SFDA RSD system.
- Submit the batch record to Document Control for archiving after reviewing and releasing are completed.
**Qualifications**:
- Minimum A minimum of 03 years experience in same operation of pharmaceutical / nutraceutical products.
- Master’s degree / Bachelor degree in Pharmacy.
- Professional Classification & Registration from SCFHS
- Knowledge of manufacturing instruments, equipment. PK and analytical studies are required.
- Excellent interpersonal, communication skills and team playing capability and ability to meet challenges and deadlines.
- Fluency in Arabic & English languages.
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